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Sacituzumab Tirumotecan in Recurrent or Metastatic Cervical Cancer After Platinum Chemotherapy and Anti-PD-L1 or Anti-PD-1 Therapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying recurrent or metastatic cervical cancer, which means cervical cancer that has come back or has spread to other parts of the body after previous treatment. The study is testing MK-2870, also called sacituzumab tirumotecan, given by intravenous infusion into a vein. The purpose of the study is to see how well MK-2870 works, how safe it is, and how it compares with other treatments chosen by the doctor.

The study is for people whose cancer has gotten worse after treatment with platinum-based chemotherapy and anti-PD-L1 or anti-PD-1 therapy, which are treatments that help the immune system fight cancer. Treatment of physician’s choice may include topotecan, tisotumab vedotin, irinotecan, pemetrexed, gemcitabine, or vinorelbine, and some medicines may be given with supportive care such as paracetamol, H2-receptor antagonists, and glucocorticoids to help reduce side effects. The study is randomized, which means treatment is assigned by chance, and it is open-label, which means both the study team and the participant know which treatment is being given.

The study has an initial part and then a larger comparison part. In the first part, MK-2870 is given to gather early information about how it acts in the body and how well it is tolerated. In the main part, MK-2870 is compared with other available cancer treatments. Treatment is given over time, with regular study visits and checks for side effects and general health while the cancer is being followed.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Start of study treatment

    After joining the study, you begin study treatment for recurrent or metastatic cervical cancer, which means cancer that has returned or has spread to other parts of the body.

    Your treatment depends on the study group assigned to you. One group receives MK-2870, also called sacituzumab tirumotecan, given as an intravenous infusion at a dose of 4 mg/kg. An intravenous infusion means medicine given through a vein.

    The other group receives treatment of physician’s choice, which may include one of the following medicines given by intravenous infusion: topotecan 6.25 mg/m2, irinotecan hydrochloride 400 mg/m2, pemetrexed disodium 500 mg/m2, gemcitabine hydrochloride 2000 mg/m2, or vinorelbine 60 mg/m2. The study also lists tisotumab vedotin as a comparator treatment, but no dose is specified in the source data.

    Background medicines may also be used during treatment. These include paracetamol, antihistamines (medicines that help reduce allergy-type reactions), h2-receptor antagonists (medicines that reduce stomach acid), and glucocorticoids (steroid medicines). The source data does not give a dose, frequency, or duration for these background medicines.

  2. Step 2

    During treatment and follow-up assessments

    While you are receiving treatment, the study checks how well the medicine works. The main measure is whether the cancer shrinks or disappears, which is called objective response rate or ORR. RECIST 1.1 is a set of rules used to measure tumor size on scans, and BICR means the scan results are reviewed by independent experts who are not part of the study team.

    Your safety is monitored during the study. The study records adverse events, which are unwanted medical problems that happen during treatment, and notes whether treatment is stopped because of an adverse event.

    The study also measures overall survival, which is the length of time patients remain alive after treatment begins.

    In the phase 3 part of the study, the trial also checks progression-free survival, which is the length of time before the cancer gets worse, duration of response, which is how long a tumor response lasts, and time to deterioration, which is the time until health or symptoms worsen.

    Quality of life is also assessed using the EORTC QLQ-C30, a questionnaire about how you feel and how well you can carry out daily activities. The study looks at the global health status/quality of life, physical functioning, and role functioning scores.

  3. Step 3

    End of study period

    The study continues until the planned end of the trial period. The estimated study dates run from 2024-06-28 to 2028-06-15.

    The source data does not specify the exact length of treatment for each medicine, how often each dose is given, or the full schedule of visits.

Who can join the trial?

11 criteria

  • Have a confirmed diagnosis by tissue testing of one of these cervical cancer types: squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma. These are different types of cancer based on how the tumor cells look under a microscope.
  • Have recurrent or metastatic cervical cancer. Recurrent means the cancer has come back after treatment. Metastatic means the cancer has spread to other parts of the body.
  • Have cancer that has progressed after or during treatment with platinum-doublet chemotherapy and anti-PD-L1/anti-PD-1 therapy. Platinum-doublet chemotherapy means treatment with two chemotherapy medicines, one of which is a platinum drug. Anti-PD-L1/anti-PD-1 therapy means a type of immunotherapy that helps the immune system attack cancer.
  • Have measurable disease on scans according to RECIST 1.1. This means the tumors are large enough to be measured in a standard way on imaging tests. If a tumor is in an area that was previously treated with radiation, it can still count if it has clearly gotten worse.
  • Have adequate organ function. This means the major organs, such as the liver, kidneys, and bone marrow, are working well enough for study treatment.
  • Be female at birth and be at least 18 years old when signing the consent form.
  • Have an ECOG performance status of 0 or 1 shortly before starting study treatment. ECOG performance status is a scale of how well a person can do daily activities. A score of 0 means fully active, and 1 means restricted in heavy physical work but able to do light work.
  • Provide a sample of tumor tissue, preferably the most recent sample, taken from a core biopsy or excisional biopsy of a tumor that has not been treated with radiation. A core biopsy removes a small cylinder of tissue, and an excisional biopsy removes the whole tumor or a larger part of it.
  • If living with HIV, have the infection well controlled while taking antiretroviral therapy (ART). ART is treatment that lowers the amount of HIV in the body.
  • If hepatitis B surface antigen is positive, have taken hepatitis B antiviral treatment for at least 4 weeks and have undetectable hepatitis B virus levels before starting the study. Hepatitis B surface antigen is a blood marker showing hepatitis B infection, and undetectable means the virus level is too low to be found by the test.
  • If there is a history of hepatitis C, have undetectable hepatitis C virus levels at screening. Screening means the tests done before joining the study.

Who cannot join the trial?

16 criteria

  • Has Grade 2 or higher peripheral neuropathy, meaning moderate or worse nerve damage that can cause numbness, tingling, or pain, usually in the hands or feet.
  • Has active central nervous system (CNS) metastases, meaning cancer that has spread to the brain or spinal cord and is currently active, and/or has carcinomatous meningitis, meaning cancer cells in the fluid or lining around the brain and spinal cord.
  • Has an active infection requiring systemic therapy, meaning an infection that needs treatment affecting the whole body, such as antibiotics by mouth or through a vein.
  • Has HIV infection with a history of Kaposi’s sarcoma or Multicentric Castleman’s Disease, which are serious conditions linked to HIV.
  • Has both active hepatitis B and active hepatitis C infection, meaning ongoing viral infections of the liver.
  • Has had a severe allergic reaction to sacituzumab tirumotecan, treatment of physician’s choice, any ingredient in these treatments, or another biologic therapy (a treatment made from living cells or proteins).
  • Has not fully recovered from a major surgery or still has surgical complications, meaning problems caused by the surgery.
  • Has a history of pneumonitis or interstitial lung disease (ILD) that needed steroids, or has this lung condition now. Pneumonitis and ILD mean inflammation or scarring in the lungs.
  • Has a history of severe dry eye syndrome, severe Meibomian gland disease, severe blepharitis (eyelid inflammation), or severe corneal disease that would slow or prevent healing of the clear front part of the eye.
  • Has active inflammatory bowel disease needing medicines that suppress the immune system, or has had inflammatory bowel disease before, such as Crohn’s disease, ulcerative colitis, or chronic diarrhea.
  • Has uncontrolled, significant heart or blood vessel disease or uncontrolled, significant cerebrovascular disease, meaning serious problems with the heart, blood vessels, or blood flow to the brain that are not well managed.
  • Has received prior systemic anticancer therapy, meaning earlier cancer treatment that works throughout the body.
  • Has received radiotherapy within 2 weeks before the study starts, or has radiation-related toxicities that need corticosteroids, meaning side effects from radiation that require steroid medicine.
  • Has received a live or live-attenuated vaccine within 30 days before the first study dose. Live vaccines contain weakened germs; killed vaccines are allowed.
  • Has a cervical cancer type other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, or has a nonepithelial cancer of the cervix, such as sarcoma or neuroendocrine tumor.
  • Has another active cancer that is getting worse or has needed treatment within the past 3 years.
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Investigated drugs

  • MK-2870

    is the study medicine being tested in this trial. It is given by intravenous infusion, which means it is put directly into a vein through a drip. The trial is looking at how well it works on recurrent or metastatic cervical cancer, and also checking how safe it is and how well people tolerate it.

  • Topotecan

    is one of the treatment options in the physician’s choice group. It is given by intravenous infusion. In this trial, it serves as one of the standard cancer treatments that may be used instead of MK-2870 so the researchers can compare how the study medicine performs against usual care.

  • Tisotumab vedotin

    is another treatment option in the physician’s choice group. It is given as an infusion into a vein. It is used as a comparator treatment, meaning it is one of the existing medicines doctors may choose for participants in the control group to compare against MK-2870.

  • Irinotecan

    is another comparator treatment given by intravenous infusion. It is a chemotherapy medicine that may be used as part of the doctor’s choice treatment group. The trial compares it with MK-2870 to see which treatment works better and how the side effects compare.

  • Pemetrexed

    is another chemotherapy medicine in the physician’s choice group. It is given by intravenous infusion. In this study, it is one of the standard treatment options used to compare with MK-2870 for effectiveness and safety.

  • Gemcitabine

    is another comparator chemotherapy given by intravenous infusion. It is part of the treatment choices doctors may use for participants in the control group. The study uses it to compare usual treatment with the new study medicine.

What is already known about the treatment

  • MK-2870

    Sacituzumab tirumotecan is given by intravenous infusion, meaning it is placed directly into a vein by a healthcare professional. It is an investigational cancer medicine and is still being studied in medical literature for people with advanced cancers, including recurrent or metastatic cervical cancer. It is an antibody-drug conjugate, which means it combines a targeted antibody with a cancer-killing drug to deliver treatment more directly to cancer cells. Its main use is being explored for cancers that have returned or spread after earlier treatment, and it works by binding to a target on cancer cells and releasing the active drug inside them to damage and kill the cells.

  • Topotecan

    Topotecan is given by intravenous infusion into a vein under medical supervision. It is an approved cancer medicine and is well described in medical literature, where it has been used for several types of cancer, including cervical cancer. It belongs to a group called topoisomerase I inhibitors, which are drugs that block an enzyme cancer cells need to copy and repair their DNA. By stopping this enzyme, topotecan causes DNA damage in fast-growing cancer cells and helps slow or stop their growth.

  • Tisotumab vedotin

    Tisotumab vedotin is given as an infusion into a vein by a healthcare professional. It is an approved and actively studied cancer medicine in medical literature, especially for cervical cancer. It is an antibody-drug conjugate, which means it uses a targeting antibody to find cancer cells and carry a cell-killing drug to them. It is classified as a targeted anticancer medicine, and it works by binding to a cell-surface target, then releasing the attached drug inside the cancer cell to damage it and lead to cell death.

  • Irinotecan

    Irinotecan is given by intravenous infusion into a vein. It is an established cancer medicine and is widely used in medical practice and medical literature for several cancers, including some cases of cervical cancer. It is a topoisomerase I inhibitor, a type of chemotherapy that stops an enzyme needed for DNA copying and repair. This causes DNA damage in cancer cells, which makes it harder for them to grow and survive.

  • Pemetrexed

    Pemetrexed is given by intravenous infusion into a vein. It is an approved cancer medicine and is well known in medical literature, mainly for certain lung cancers and other solid tumors. It is an antifolate chemotherapy drug, which means it blocks the use of folate, a vitamin that cells need to make DNA and grow. By interfering with several enzymes involved in DNA building, pemetrexed helps slow the growth of cancer cells.

  • Gemcitabine

    Gemcitabine is given by intravenous infusion into a vein. It is an approved and commonly used chemotherapy medicine with a long history in medical literature for several cancers, including cervical cancer. It is a nucleoside analog, meaning it acts like a natural building block of DNA but is faulty. When cancer cells use it, the drug disrupts DNA making and stops the cells from dividing normally.

Investigated diseases

Recurrent cervical cancer - A cancer that starts in the cervix and comes back after treatment. It may grow again in the pelvis or spread to other parts of the body. Metastatic cervical cancer - A cervical cancer that has spread beyond the cervix to other organs or tissues. It can gradually spread further and involve more areas over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508323-12-00Protocol codeMK-2870-020Estimated enrolment747 patientsSponsorMerck Sharp & Dohme LLC

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